Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
15 participants
INTERVENTIONAL
2023-03-07
2023-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Theory based upon systematic review: Given adequate vestibular activation through targeted activities (in an otherwise under-performing vestibular system), myelination and neuroplasticity propagate along learning pathways leading to greater neural connectivity and efficiency for sequencing, ordinance, attention, memory, body schema, spatial cognition, executive function, and interoception.
As a result of prescribed vestibular interventions and gained attributes supporting learning, students will experience increased academic growth and success as outlined by the following model.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Classroom interventions
Students within five classrooms will engage in prescribed vestibular activities embedded within learning curricula to determine the impact of the intervention on learning outcomes, particularly memory, sequencing, attention, and ordinance related outcomes.
VestibulOTherapy
For this study, the following activity-orientated interventions will occur within the natural learning environments so that generous opportunities exist for neural plasticity and growth.
Each student will be engaged in 20-30 minutes/day of intermittent classroom activities, plus 20-30- minutes of daily stability work embedded into classroom routines including stabilizing self on a Hokki stool or t-stool or standing on a balance board during sedentary work, such as circle time or read-a-loud.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VestibulOTherapy
For this study, the following activity-orientated interventions will occur within the natural learning environments so that generous opportunities exist for neural plasticity and growth.
Each student will be engaged in 20-30 minutes/day of intermittent classroom activities, plus 20-30- minutes of daily stability work embedded into classroom routines including stabilizing self on a Hokki stool or t-stool or standing on a balance board during sedentary work, such as circle time or read-a-loud.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* between the ages of 6-10 years of age
* performance challenges in school in the areas of math, spelling, organization, sequencing, attention, or engagement
* demonstrate attributes of vestibular dysfunction per the Vestibular Profile
* may have ADD or ADHD
* May have challenges with speech articulation
* good potential for learning and engaging in prescribed interventions
Exclusion Criteria
* Absence of vestibular challenges
* Absence of learning challenges.
* unable to participate in interventions on a routine basis due to attendance or other limitations.
6 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Wisconsin, La Crosse
OTHER
Boston University
OTHER
VestibulOTherapy
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Constance L Wall, OTD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
School District of La Crosse
La Crosse, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Besnard S, Tighilet B, Chabbert C, Hitier M, Toulouse J, Le Gall A, Machado ML, Smith PF. The balance of sleep: Role of the vestibular sensory system. Sleep Med Rev. 2018 Dec;42:220-228. doi: 10.1016/j.smrv.2018.09.001. Epub 2018 Sep 8.
Hitier M, Besnard S, Smith PF. Vestibular pathways involved in cognition. Front Integr Neurosci. 2014 Jul 23;8:59. doi: 10.3389/fnint.2014.00059. eCollection 2014.
Emami Kashfi T, Sohrabi M, Saberi Kakhki A, Mashhadi A, Jabbari Nooghabi M. Effects of a Motor Intervention Program on Motor Skills and Executive Functions in Children With Learning Disabilities. Percept Mot Skills. 2019 Jun;126(3):477-498. doi: 10.1177/0031512519836811. Epub 2019 Mar 16.
Lopez C, Toupet M, van Nechel C, Bozorg Grayeli A. Editorial: Role of Inner Ear in Self and Environment Perception. Front Neurol. 2020 Feb 20;11:22. doi: 10.3389/fneur.2020.00022. eCollection 2020. No abstract available.
Lotfi Y, Rezazadeh N, Moossavi A, Haghgoo HA, Rostami R, Bakhshi E, Badfar F, Farokhi Moghadam S, Sadeghi-Firoozabadi V, Khodabandelou Y. Rotational and Collic Vestibular-Evoked Myogenic Potential Testing in Normal Developing Children and Children With Combined Attention Deficit/Hyperactivity Disorder. Ear Hear. 2017 Nov/Dec;38(6):e352-e358. doi: 10.1097/AUD.0000000000000451.
Mast FW, Preuss N, Hartmann M, Grabherr L. Spatial cognition, body representation and affective processes: the role of vestibular information beyond ocular reflexes and control of posture. Front Integr Neurosci. 2014 May 27;8:44. doi: 10.3389/fnint.2014.00044. eCollection 2014.
Matuszkiewicz M, Galkowski T. Developmental Language Disorder and Uninhibited Primitive Reflexes in Young Children. J Speech Lang Hear Res. 2021 Mar 17;64(3):935-948. doi: 10.1044/2020_JSLHR-19-00423. Epub 2021 Feb 23.
Melo RS, Lemos A, Paiva GS, Ithamar L, Lima MC, Eickmann SH, Ferraz KM, Belian RB. Vestibular rehabilitation exercises programs to improve the postural control, balance and gait of children with sensorineural hearing loss: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109650. doi: 10.1016/j.ijporl.2019.109650. Epub 2019 Aug 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
03072023
Identifier Type: -
Identifier Source: org_study_id